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  5. Label Information: Sani Schutz

FDA Label for Sani Schutz

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT(S)
    3. PURPOSE
    4. USE
    5. WARNINGS
    6. DO NOT USE
    7. OTC - WHEN USING
    8. OTC - STOP USE
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

Sani Schutz Product Label

The following document was submitted to the FDA by the labeler of this product Schutz Na Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



The hand rub is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  • Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerol (0.56% v/v).
  • Hydroxyethylcellulose (2.23% v/v).
  • Sodium Lactate (0.50% v/v).
  • Vitamin E (0.44% v/v)
  • Sterile distilled water or boiled cold water.

    • The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.


Active Ingredient(S)



Alcohol 75% v/v. Purpose: Antiseptic


Purpose



Antiseptic, Hand Rub


Use



Health care personnel hand rub to help reduce bacteria that potentially can cause disease.


Warnings



For external use only. Flammable. Keep away from heat or flame


Do Not Use



  • in children less than 2 months of age
  • on open skin wounds

Otc - When Using



When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Otc - Stop Use



Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information



  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients



glycerin, hydroxyethylcellulose, vitamin e, purified water


Package Label - Principal Display Panel



5 L (5000 mL) NDC: 78555-001-04


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